How has the African vaccine manufacturing landscape changed in the last year?

October 18, 2024 by PATH

Updated analysis from Africa CDC, CHAI, and PATH can help inform pathways forward.

Hands holding a vaccine

Building sustainable vaccine manufacturing capacity in Africa will be a complex effort that requires coordination across multiple stakeholders and sectors. Photo courtesy of Clinton Health Access Initiative.

Africa has long relied on other parts of the world for its vaccine supply. This inequitable global health structure creates barriers to access and leaves the continent vulnerable to threats like the COVID-19 pandemic. African leaders have voiced this struggle for years, but the delay Africa faced in receiving COVID-19 vaccines thrust the issue onto the global stage. It prompted African leaders to create the Partnership for African Vaccine Manufacturing with an ambitious goal of locally manufacturing 60 percent of Africa’s vaccine needs by 2040. It also spurred international action and investment toward building a sustainable vaccine manufacturing landscape in Africa.

However, reaching African leaders’ goal of increasing the continent’s vaccine manufacturing capacity will be challenging. It will be a multi-year, complex effort that requires coordination across multiple stakeholders and sectors. With many new projects on the horizon, there’s a risk of duplicative investments in some areas and under-investment in others. In the long term, this could jeopardize impact and undermine manufacturers’ market viability.

Recognizing this challenge, one year ago, the Africa Centres for Disease Control and Prevention (Africa CDC), the Clinton Health Access Initiative (CHAI), and PATH worked together to map the state of vaccine manufacturing in Africa. Together, we generated insights into what’s needed to develop a robust and sustainable vaccine manufacturing ecosystem. In 2024, we’ve been working to refine our original research. We surveyed African vaccine manufacturers to understand their current manufacturing capacity and capabilities, the progress they’ve made in the last year, and their future outlooks. This information can help stakeholders and funders better coordinate and prioritize actions to build a successful African vaccine manufacturing ecosystem.

What have we learned? And how should we move forward?

A deeper dive

Last year’s research showed us what vaccine manufacturing projects were active on the African continent and it yielded many important takeaways that hold true today. Africa still faces an imbalance between insufficient drug substance (the antigen that makes up the active vaccine component) and excess drug product (the final vaccine product) manufacturing capacity, as well as highly uncertain country demand for African-made vaccines. In the 2024 research, however, we sought to provide nuance to our previous estimates and give those takeaways more impact.

Importantly, we also sought to clarify questions around demand for African-made vaccines. We wanted to understand whether countries are considering and/or prepared to buy African-made vaccines and what support is needed to improve country commitments to them. If the demand isn’t there—or isn’t known—manufacturers will struggle to find success.

Africa still faces an imbalance between insufficient drug substance and excess drug product manufacturing capacity, as well as highly uncertain country demand for African-made vaccines.

The 'new' current state of African vaccine manufacturing

As of June 2024 (when we completed our manufacturer surveys), we found there are 25 active vaccine projects across the African continent in roughly three different stages of project and facility maturity: five manufacturers have commercial-scale manufacturing facilities with technology transfers signed or underway; five manufacturers have commercial-scale manufacturing facilities but have yet to sign technology transfers; and 15 additional manufacturers are still in earlier stages of development.

We’ve also seen estimates of Africa’s drug product manufacturing capacity decrease by 40 percent from 2023 estimates to 1.4 billion doses annually. This may sound bad but is actually a step in the right direction, given Africa currently faces excess drug product capacity. Moreover, the reduction in capacity represents a reallocation to other health commodities that are crucial to the African health care system, such as insulin and oncology biologics.

In addition, three manufacturers have advanced their drug substance manufacturing projects since 2023. This is an important step forward given the continent’s significant lack of capacity to produce drug substance. Together, these drug substance and drug product capacity changes signal a slight shift toward balance—encouraging for the long-term outlook.

Finally, a significant number of technology transfer discussions are underway; 10 transfers have begun and three more have been signed and are awaiting initiation—another sign of progress.

Putting the research in context

Africa’s vaccine manufacturing ecosystem is moving toward sustainability—but still has a long way to go. Despite the progress made in the last year, capacity to produce drug product on the continent still far exceeds the anticipated demand for African-made products in an already-crowded marketplace. Currently, installed capacity is estimated at 1.4 billion doses for 2030, which could surge to 2 billion doses annually in emergency situations. If more projects come online, that capacity will only grow—a scenario that threatens market health and manufacturers’ commercial viability. At the same time, drug substance production remains limited at 61 million doses annually. And, much of the installed drug substance capacity is for mRNA vaccines—which currently have limited commercial market opportunities. Even when drug substance expansion plans are taken into consideration, there won’t be enough capacity to meet Africa’s vaccine production goals and ensure pandemic preparedness.

Current plans show that between 2025 and 2030, three African vaccine manufacturers are expected to produce and secure World Health Organization prequalification for nine different vaccines—despite the fact there is currently uncertain market demand for these vaccines.

In a nutshell, Africa has the ambition and much of the means to meet its vaccine production goals, but it doesn’t yet have the certainty of demand nor the business case to support that ambition.

So, how can stakeholders and investors who want to support sustainable African vaccine manufacturing help?

Africa has the ambition and much of the means to meet its vaccine production goals, but it doesn’t yet have the certainty of demand nor the business case to support that ambition.

Understanding the market for African-made vaccines

Investments in African vaccine manufacturing must be made strategically. For instance, investors can focus on drug substance production over drug product production. This can help correct the imbalance Africa’s vaccine manufacturing landscape currently faces and promote market health and pandemic preparedness. Supporting technology transfers and/or continental investments into research and development to strengthen drug substance production capabilities and capacity would also have strategic value.

However, for the manufacturing ecosystem to truly be sustainable, demand is the other key element. Countries should begin to critically consider where a vaccine is manufactured when making procurement decisions. By directing their decision-making power toward African-made vaccines, countries can help clarify and confirm demand. This could have a cascading effect that would help resolve pending challenges that African vaccine manufacturers face.

Building the way forward

Progress is being made on the demand issue; in May 2024, at a meeting hosted by Africa CDC on the sidelines of the 76th World Health Assembly, African health ministers committed to purchasing vaccines manufactured in Africa. Their commitments signified an effort to strengthen the manufacturing ecosystem and ensure sustainable vaccine access across the continent. Africa CDC, in partnership with Gavi and CHAI, is currently engaging with key African country governments to determine how these commitments can be made a reality.

Building a sustainable, continental vaccine manufacturing ecosystem is no small challenge and progress is not always consistent. However, through continued, collaborative effort—like this partnership between Africa CDC, CHAI, and PATH—we will move the needle ever forward. Together, we can help improve vaccine access for the more than a billion people living across Africa.

This work was made possible by the support of the American people through the United States Agency for International Development (USAID) and by funding from the Bill & Melinda Gates Foundation. The contents do not necessarily reflect the views of USAID or the United States Government, or the Bill & Melinda Gates Foundation.